# K140941: Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: May 7, 2014 after 23 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K991400 (1999). 12 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101197: Parie Tene Progrip Mesh, Sofradim Production (2010) Summary page 2.
- K991400: Parietene Polypropylene Mesh, Sofradim Production (1999) Summary page 2.

## Most influential descendants
- K142091: Parietene Macroporous Mesh (2014), 2 descendants of its own
- K223218: Parietene Macroporous Mesh (2022), 1 descendant of its own
- K253125: Parietene™ Flat Sheet Mesh (2025), 0 descendants of its own
- K250869: Parietene™ Macroporous Mesh  (PPM5050 ) (2025), 0 descendants of its own
- K220540: ProGrip Self-Gripping Polypropylene Mesh (2022), 0 descendants of its own

## Indications for use
PROGRIPTM Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair. ParieteneTM Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissue and abdominal wall hernia repair.

Source page: https://510kreport.com/device/K140941
Methodology: https://510kreport.com/methodology